By Ransdell Pierson
Dec 12 By a lopsided vote of 13 to 1, an
independent committee of medical experts voted on Thursday to
recommend approval of a new type of diabetes drug from
Bristol-Myers Squibb that U.S. regulators rejected two
years ago due to safety concerns.
The advisory panel to the U.S. Food and Drug Administration
said the benefits of the medicine, called dapaglifozin, appear
to outweigh its risks. Bristol-Myers is developing the drug,
which is already approved in Europe, in partnership with
The FDA typically follows the advice of its advisory panels,
but is under no obligation to do so.
In another vote, by 10 to 4, the panel found the drug
appeared to have a favorable cardiovascular safety profile.
The FDA rejected the medicine in January 2012 after a
previous medical advisory panel said clinical data did not
provide enough certainty about its cancer and heart risks.
Some members of the panel, in a day-long meeting on
Thursday, expressed concern that 10 patients taking dapaglifozin
in a large trial were later diagnosed with bladder cancer.
But other panel members said six of those cases occurred
within months after treatment began, and were therefore probably
not related to the drug because the cancer typically takes years
Others noted that the overall incidence of all cancers in
patients taking dapaglifozin was similar to the overall
incidence seen in patients who received placebos.
"I don't think we can dismiss it," referring to the bladder
cancer risk, said panel member Dr. Milton Packer, a cardiologist
and chairman of clinical sciences with the University of Texas
Southwestern Medical Center in Dallas.
Packer said he was counting on the FDA to require the
possible bladder risk to be included in the drug's package
"I actually really like this drug," Packer said, noting that
the diabetes drug lowers blood pressure and causes weight loss,
unlike many diabetes drugs that cause weight gain.
Bristol-Myers and AstraZeneca Plc in July resubmitted their
U.S. marketing application for dapaglifozin for treatment of
adults with type 2 diabetes, the most common form of diabetes
that is highly linked to obesity.
The revised application included data from several new
studies and additional long-term data from studies previously
submitted to the FDA.
The drug blocks SGLT2, a protein that works independently of
insulin to lower blood sugar. By blocking the kidney from
reabsorbing blood sugar, the drug spurs removal of glucose
through the urine.
Dapaglifozin is sold in Europe under the brand name Forxiga.
If approved in the United States, Cowen and Co. expects the
medicine to generate annual sales of $700 million by 2020, amid
competition from similar drugs such as Johnson & Johnson's
recently approved Invokana (canaglifozin).
Invokana stirred excitement in one large trial by
controlling blood sugar better than Merck & Co's
Januvia, a blockbuster drug that belongs to a different and
relatively new class of diabetes treatments called DPP4